Description

Fluconazole Related Compound B (10 Mg) (2-(4-Fluorophenyl)-1,3-Bis(1 H-1,2,4-Triazol-1 -Yl)-Propan-2-Ol) is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for ensuring the accuracy and reliability of assays for the antifungal drug Fluconazole, helping to identify and quantify impurities. It is primarily needed by analytical laboratories, pharmaceutical R&D departments, and quality assurance units for compliance with stringent regulatory standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fluconazole active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity testing.
• Quality Control & Assurance: Enables precise impurity profiling to ensure batch-to-batch consistency and compliance with pharmacopeial monographs (USP, EP, BP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate analytical control.
• Stability Studies: Employed in forced degradation studies to understand the degradation pathways and stability profile of Fluconazole.
• Research & Development: Used in academic and industrial research focused on antifungal agents, metabolism studies, and synthetic pathway analysis.

Basic Information

Product Name	Fluconazole Related Compound B (10 Mg) (2-(4-Fluorophenyl)-1,3-Bis(1 H-1,2,4-Triazol-1 -Yl)-Propan-2-Ol)
CAS No.	81886-51-3
Molecular Formula	C13H12F1N6O1
Molecular Weight	287.27 g/mol
Synonyms	2-(4-Fluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol; Fluconazole Impurity B; Fluconazole Related Substance B; 1,3-Bis(1H-1,2,4-triazol-1-yl)-2-(4-fluorophenyl)-2-propanol; UK-48,134; Fluconazole EP Impurity B; Fluconazole USP Related Compound B
EINECS	Contact for details

Quality Control

Our Fluconazole Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the exacting standards required for use as a reference material. Certificates of Analysis (COA) detailing batch-specific results are available upon request to support your regulatory and quality documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.